Metronidazole
Metronidazole Prescribing Information
Metronidazole gel, 1% is nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea.
- Cleanse treated areas before the application of metronidazole gel.
- Apply and rub in a thin film of metronidazole gel once daily to affected area(s).
- Cosmetics may be applied after the application of metronidazole gel.
- For topical use only, not for oral, ophthalmic, or intravaginal use.
Gel, 1%. Metronidazole gel USP is a clear, colorless to pale yellow gel. Each gram of metronidazole gel USP contains 10 mg (1%) of metronidazole USP.
Lactation: Breastfeeding not recommended.(
It is not known whether metronidazole is present in human milk after topical administration. Published literature reports the presence of metronidazole in human milk after oral administration. There are no data on the effects of metronidazole on milk production. Because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with metronidazole gel.
Metronidazole gel is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation.
- Neurologic Disease:Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Peripheral neuropathy has been reported with the post approval use of topical metronidazole. Immediate reevaluate Metronidazole gel therapy if abnormal neurologic signs appear. ()5.1 Neurologic Disease
Peripheral neuropathy, characterized by numbness or paresthesia of an extremity, has been reported in patients treated with systemic metronidazole. peripheral neuropathy has been reported with the post approval use of topical metronidazole. Immediately reevaluate metronidazole gel therapy if abnormal neurologic signs appear. Administer metronidazole with caution to patients with central nervous system diseases.
- Blood Dyscrasias:Metronidazole gel is a nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia. ()5.2 Blood Dyscrasias
Metronidazole gel is a nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia.
- Contact Dermatitis:If dermatitis occurs, patients may need to discontinue use. ()5.3 Contact Dermatitis
Irritant and allergic contact dermatitis have been reported with metronidazole gel. If dermatitis occurs, patients may need to discontinue use.
- Eye Irritation:Topical metronidazole has been reported to cause tearing of the eyes. Avoid contact with the eyes. ()5.4 Eye Irritation
Topical metronidazole has been reported to cause tearing of the eyes. Avoid contact with the eyes.